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. 2021 Apr 26;5(1):37.
doi: 10.1186/s41687-021-00289-y.

Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep

Marci English  1 , Boyka Stoykova  2 , Christina Slota  3 , Lynda Doward  4 , Emad Siddiqui  2 , Rebecca Crawford  4 , Dana DiBenedetti  3
Affiliations

Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep

Marci English et al. J Patient Rep Outcomes. .

Erratum in

Abstract

Purpose: We evaluated the impact of menopause-associated vasomotor symptoms (VMS) on sleep. We also sought to establish the content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) short form Sleep-Related Impairment and Sleep Disturbance measures in postmenopausal women with moderate to severe VMS.

Methods: Cross-sectional, in-person, qualitative interviews were conducted in the United States (Texas, Illinois) and European Union (UK, France) with women aged 40-64 years experiencing moderate to severe VMS (≥35/wk). Main outcomes were impact of VMS on sleep based on concept elicitation and content validity of PROMIS Sleep-Related Impairment and Sleep Disturbance short forms via cognitive debriefing.

Results: Thirty-two women (US: n = 16; EU: n = 16) participated. A majority (US: 93.8%; EU: 93.8%) said VMS affected sleep; specifically, they had sleep interrupted by sweating or overheating and had difficulty returning to sleep. Sleep disturbance was the most bothersome aspect of VMS (US: 75%; EU: 50%). VMS-associated sleep disturbance affected next-day work productivity, mood, relationships, daily activities, concentration, social activities, and physical health. Participants found both PROMIS sleep measures relevant and easy to answer; the Sleep Disturbance measure was considered the most relevant. Participants had no difficulty remembering their experiences over the 7-day recall period and found the response options to be distinct.

Conclusion: VMS associated with menopause significantly interferes with sleep and next-day functioning (e.g., work productivity), supporting assessment of sleep outcomes in studies evaluating treatment of VMS. Women with moderate to severe VMS found that the PROMIS Sleep-Related Impairment and Sleep Disturbance short forms assessed constructs important to understanding sleep in the context of menopause-associated VMS.

Keywords: Content validity; Menopause; PRO; Quality of life; Sleep; Vasomotor symptoms.

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Conflict of interest statement

DD, CS, LD, and RC are employees of RTI Health Solutions, contracted by Astellas to design and conduct this research. ME, BS, and ES are Medical and Development employees at Astellas Pharma, Inc.

Figures

Fig. 1
Fig. 1
Areas of life impacted by VMS associated with menopause. During the concept elicitation phase, women were asked general, open-ended questions about the way VMS impacted their lives, and then asked how VMS impacted each of the specific areas shown here. Responses are categorized here to show the percentage of participants who indicated that each area is impacted by their VMS. The EU sample included participants in Paris, France, and Manchester, UK; the US sample included participants in Dallas, TX, and Chicago, IL. aIncludes 5 women who reported difficulty concentrating during hot flashes and 4 who reported that lack of sleep due to VMS made them less alert or focused the following day. VMS, vasomotor symptoms
See this image and copyright information in PMC

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